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Potential shortages of medical devices manufactured in Puerto Rico

by | Oct 24, 2017

In the wake of Hurricanes Irma and Maria, the U.S. Food and Drug Administration (FDA) has become aware and is monitoring the supply of more than forty drug products, including medical devices, manufactured by facilities in Puerto Rico. As a result of the devastation, lack of power, connectivity, transportation, clean water, raw materials and supplies have all contributed to growing concerns around the potential for critical shortages of medications and medical devices produced in fifty facilities on the island. Most of the facilities have been running on generators and although they are able to produce some products, they have not yet reached pre-hurricane production levels. The FDA has been working closely with at least ten of these companies and their suppliers to restore production as soon as possible. Although we do not supply many of the medications or devices made in these facilities, these medical devices and supplies (such as, surgical instruments, cardiac pacemakers, insulin pumps, intravenous bags,) are frequently used in hospitals and outpatient facilities during and after surgeries and to deliver life-saving medications. The FDA is fully committed to helping restore manufacturing in Puerto Rico. Until then, the FDA is taking other steps to mitigate potential shortages, such as importing devices from outside the U.S. or allowing manufacturers to shift production to alternative sites. We are sharing this information so you become aware of this situation and in the event you begin to notice increased shortages of medical devices.    

Source:
U.S. Food and Drug Administration. FDA Statement. Statement by FDA Commissioner Scott Gottlieb, M.D. on medical device manufacturing recovery in Puerto Rico. October 20, 2017. Available at https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm581436.htm





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